Thanks very much! I’m in Procurement, this will help in my meeting later with a supplier! Appreciate the resource.

The Medical Device - Risk Management Regulation is ISO 14971. The Medical Device - Quality System Regulation is ISO 13485. The Quality System Regulation is QSR 21 CFR 820. The installation location should be verified, so it meets Good Manufacturing Practices. Installation Qualification is a step-by-step list for the quality assurance of the equipment. Some inputs areDesign Failure and Mode Effect Analysis, Process Failure and Mode Effect Analysis....

Will you please elaborate each phase of equipment qualification with listed (1) how design protocol, what is the basic approach and require thing to design protocol, reference of protocol design (2) any common considerations in protocol design irrespective of equipment make mechanism function etc. Eg. Safety, risk assessment, challenge studies, product runs like that are any more. (3) what we have to do if we observed non intrensic failures of equipment qualification (4) how to schedule calibration, preventive maintenance (5) how we can recommend preventive maintenance, in what way, what we need, and references of preventive maintenance etc etc

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Very nice. I am instrumentation engineer 2017 batch. After completion of degree I started working in automation field ( I have done oq ,pq of blender, RMG ,FBD machine also 21 cfr part 11 with end client. ) now I have 1 yr experience in automation field.since salary package is very less so now I am thinking to switch to pharma sector, I have one question what should I do now shall I switch to pharma or not? Plz reply..

Heart of Medical Industry

Your headline is wrong. They present a qualification process. A Process Validation (PV) is carried out after completion of qualification of production line.!

Great work! this video contains useful information and excellent animation to explain the concept.

You try to give the video more brightness it will be great if you do

Thank you , a course I am doing did not explain it well , you did a great job thank you .

Very useful information for me. Can you please update how can i write a test for OQ and PQ/

Very good and funny videos bring a great sense of entertainment!

thank you.

Thank you for the presentation , really helpfully 😊

Do we need PQ on post sterile products or only pre sterilized? Please someone answer this. Thanks

Tq

Thank you.. Very informative video . keep it upi . Just love your youTube channel :)

Thank You

Thanks for sharing

Great! Thank you.

thanks sir ji

the video image is too poor, you need to fix it more

Thank you Aman

Thanks

Thank you so much

Very nice one

This would have been easier to understand if Steven Hawking had read it to us.

Thank you sir,,, pharma code kase nikale solution batao

nice , thank you..

Tq brother

Good information

DQ?

you need to clarify the content

How come here for their job.. please like

plz Hindi me baniye video

CovidImages need to be invested more than half19